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Hetero emerges 1st in world to bag WHO PQ for generic version of Pfizer’s Covid-19 oral drug Paxlovid | India News
HYDERABAD: Pharmaceutical Player heterosexual Group on Monday said it has emerged as the first in the world to receive World Health Organizationdrug prequalification program (WHO-PQ) for the generic version of the Covid-19 oral antiviral treatment candidate Nirmatrelvirtogether with Ritonavir used as part of Pfizer‘S Paxlovid.
“This is the first prequalification for a generic version of Pfizer’s Covid-19 oral antiviral drug Paxlovid, which WHO calls the best treatment option for high-risk patients to date,” said Hetero. .
The company said it will launch a generic combination pack under the NIRMACOM brand that will contain Nirmatrelvir 150mg and Ritonavir 100mg tablets. The tablets will be sold by prescription only and must be started within five days of the onset of Covid-19 symptoms, it added. According to Hetero, the Nirmacom will be manufactured at its facilities in Hyderabad.
Calling the WHO PQ for Nirmacom an important milestone in the fight against Covid-19, Vamsi Krishna Bandi, chief executive officer of the Hetero Group, said: “It allows us to expand our access to antiretroviral drugs. this important innovative virus for those in need. We are committed to deliver NIRMACOM faster at affordable prices across 95 LMICs including India.”
“We are pleased to see the first generic version of nirmatrelvir, under the MPP license with Pfizer, receive quality assurance approval from WHO,” said Charles Gore, Executive Director of the Drug Patent Group (MPP). This is an impressive achievement for Hetero as we announced sub-licensing agreements just nine months ago. With Covid-19 cases on the rise again, we need to make treatments available in the LMICs so that no one is left behind.”
Hetero has entered into a non-exclusive voluntary licensing agreement with MPP to manufacture and sell a generic version of Pfizer’s Covid-19 oral antiviral candidate nirmatrelvir, packaged with ritonavir, at LMICs.
Hetero has received emergency use authorization (EUA) from the Directorate General of Drugs Control of India (DCGI) to manufacture and market NIRMACOM.
WHO has made strong recommendations on Nirmatrelvir and Ritonavir for patients with mild and moderate Covid-19 who are at highest risk of hospitalization, such as unvaccinated, elderly or immunosuppressed patients.
“This is the first prequalification for a generic version of Pfizer’s Covid-19 oral antiviral drug Paxlovid, which WHO calls the best treatment option for high-risk patients to date,” said Hetero. .
The company said it will launch a generic combination pack under the NIRMACOM brand that will contain Nirmatrelvir 150mg and Ritonavir 100mg tablets. The tablets will be sold by prescription only and must be started within five days of the onset of Covid-19 symptoms, it added. According to Hetero, the Nirmacom will be manufactured at its facilities in Hyderabad.
Calling the WHO PQ for Nirmacom an important milestone in the fight against Covid-19, Vamsi Krishna Bandi, chief executive officer of the Hetero Group, said: “It allows us to expand our access to antiretroviral drugs. this important innovative virus for those in need. We are committed to deliver NIRMACOM faster at affordable prices across 95 LMICs including India.”
“We are pleased to see the first generic version of nirmatrelvir, under the MPP license with Pfizer, receive quality assurance approval from WHO,” said Charles Gore, Executive Director of the Drug Patent Group (MPP). This is an impressive achievement for Hetero as we announced sub-licensing agreements just nine months ago. With Covid-19 cases on the rise again, we need to make treatments available in the LMICs so that no one is left behind.”
Hetero has entered into a non-exclusive voluntary licensing agreement with MPP to manufacture and sell a generic version of Pfizer’s Covid-19 oral antiviral candidate nirmatrelvir, packaged with ritonavir, at LMICs.
Hetero has received emergency use authorization (EUA) from the Directorate General of Drugs Control of India (DCGI) to manufacture and market NIRMACOM.
WHO has made strong recommendations on Nirmatrelvir and Ritonavir for patients with mild and moderate Covid-19 who are at highest risk of hospitalization, such as unvaccinated, elderly or immunosuppressed patients.
